Move Together Boston Feasibility Pilot (Sit Less, Move More App for Black Breast Cancer Survivors & At-Risk Relatives)

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT05011279
Collaborator
University of Massachusetts, Boston (Other), University of Rochester (Other), National Cancer Institute (NCI) (NIH)
31
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Study Details

Study Description

Brief Summary

The purpose of this study is to develop and test a mobile app for Black/African American breast cancer survivors and their relatives, called Move Together, that promotes sitting less and moving more for better health.

Condition or Disease Intervention/Treatment Phase
  • Other: Move Together app/Garmin Activity Tracker
N/A

Detailed Description

The purpose of this study is to develop and test a mobile app for Black/African American breast cancer survivors and their relatives, called Move Together, that promotes sitting less and moving more for better health.

This is a cross-sectional descriptive study using structured interviews and qualitative data analysis to develop an intervention, followed by a pilot test of the intervention with pre- /post- measures.

  • In study phase 1,involved qualitative interviews with 5 community leader key informants, 9 breast cancer survivors and 6 first degree relatives of a survivor.

  • This part of the research study is a Pilot Study, which means it is the first time that researchers are studying usability and acceptability of the Move Together app.

  • Participants in the pilot study will participate as members of family-based dyads (n=10 dyads). One member of each dyad will be a breast cancer survivor and one will be a blood relative

  • Study involves screening for eligibility, interviews, questionnaires, Use of Move Together app with Garmin activity tracker watch

  • Participation on the trial will be for 5 weeks

  • About 20 people (10 survivors with 10 relatives) will participate in this part of the study, and a total of 58 people in the whole study.

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
"Sitting Less, Moving More": Designing a Digital Health Intervention for Black and African American Women Breast Cancer Survivors and Their At-risk Relatives (Phase II)
Actual Study Start Date :
Sep 10, 2021
Actual Primary Completion Date :
Jan 21, 2022
Actual Study Completion Date :
Jan 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pilot Study

Participants in the pilot study will participate as members of family-based dyads (n=10 dyads). One member of each dyad will be a breast cancer survivor and one will be a blood relative. Study involves interviews, questionnaires, Use of Move Together app with Garmin activity tracker watch

Other: Move Together app/Garmin Activity Tracker
The Move Together app allows users to set daily goals for increasing physical activity and decreasing sedentary time, track progress on goals, message their buddy, and access external educational infographics and other resource links. Garmin activity tracker in this study is for participants to track their steps and sedentary time.

Outcome Measures

Primary Outcome Measures

  1. System Usability Scale (SUS) score [Baseline to 4 Weeks]

    The acceptability of the Move Together app will also be assessed with The System Usability Scale (SUS) score. The scale has 10 items. Scores range from 0-100; a SUS score above a 68 is considered above average (https://www.usability.gov/how-to-and-tools/methods/system-usability-scale.html.)

Secondary Outcome Measures

  1. Number of participants screened per month [Baseline to 4 Weeks]

    Measurement will be assessed by the completion rates at each time point divided by the number of participants enrolled at each time point

  2. Number of participants enrolled per month [Baseline to 4 Weeks]

    Measurement will be assessed by the completion rates at each time point divided by the number of participants enrolled at each time point

  3. Completion Rate [Baseline to 4 Weeks]

    rate of 70% of all participants completing each of these components per protocol

  4. Percentage of study days [Baseline to 4 Weeks]

    percentage of study days in which the participant uses the Move Together app and will describe engagement with the app. Achieving a minimum of using any app feature 4 out of 7 days will provide an indication of acceptability

  5. Percentage of participants recruited [Baseline to 4 Weeks]

    Percentage of initial respondents who consent and enroll. Achieving a minimum of enrolling 3 dyads per month as an indication of feasibility of recruitment.

  6. Percentage of participants completed study [Baseline to 4 Weeks]

    Achieving a minimum of 70% of those enrolled who complete all study data collection time-points will serve as an indication of the feasibility of the proposed study protocol

  7. Number of participants retained at the end of 4 weeks [Baseline to 4 Weeks]

    Retention will be the number who remain in the study at the end of 4 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 1a) Key informants (for interviews)

  • Members of the community/advisory groups, community health centers, or faith-based network members (e.g., Pink and Black, Faces of Faith).

  • English speaking adults.

  • (1b) Breast cancer survivors and relatives (for interviews)

  • Self-identify as Black or African American

  • Age 18 and over

  • English speaking

  • Female breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a first degree blood relative (parent, child, or full sibling), of any gender, of a so defined breast cancer survivor

  • Self-report ever using a smart phone

  • (2) Breast cancer survivors and relatives (for user testing/interviews)

  • Self-identify as Black or African American

  • Age 18 and over

  • English speaking

  • Female breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a first degree blood relative (parent, child, or full sibling), of any gender, of a so defined breast cancer survivor

  • Self-report willing/able to download the app for testing on a smart phone

  • Self-report willing/able to meet via Zoom for interview

  • (3) Breast cancer survivors and relatives/"buddies" (for pilot testing)

  • Self-identify as Black or African American

  • Age 18 and over

  • English speaking

  • Breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a blood relative, of any gender, of a so defined breast cancer survivor

  • Self-report willing/able to participate with a blood relative in survivor relative dyad

  • Self-report willing/able to download the app for use on a smart phone

  • Self-report willing/able to meet via Zoom for instructions and interview

Exclusion Criteria:
  • (1a) Key informants (for interviews)

--None

  • (1b) Breast cancer survivors and relatives (for interviews)

  • Requires medically supervised physical activity (Physical Activity Readiness Question for Everyone, PAR-Q+, Question 7)

  • Pregnant women

  • (2) Breast cancer survivors and relatives (for user testing/interviews)

  • Requires medically supervised physical activity (Physical Activity Readiness Question for Everyone, PAR-Q+, Question 7)

  • Pregnant women

  • (3) Breast cancer survivors and relatives/"buddies" (for pilot testing)

  • Meets exclusion criterion of the Modified Physical Activity Readiness Questionnaire (PAR-Q) (modified)

  • Participated in interviews or user testing in prior phases of the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dana Farber Cancer Institute Boston Massachusetts United States 02115
2 University of Massachusetts Boston Boston Massachusetts United States 02125
3 University of Rochester Rochester New York United States 14627

Sponsors and Collaborators

  • Dana-Farber Cancer Institute
  • University of Massachusetts, Boston
  • University of Rochester
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Catherine Marinac, PhD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Catherine Marinac, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT05011279
Other Study ID Numbers:
  • 20-104
  • U54CA156732
First Posted:
Aug 18, 2021
Last Update Posted:
Feb 7, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Catherine Marinac, PhD, Principal Investigator, Dana-Farber Cancer Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 7, 2022